Download Recombinant DNA Categories vs. Review Bodies

Recombinant DNA Categories vs. Review Bodies
As described in Section 3 of the NIH Guidelines, the Institutional Biosafety Committee
functions on behalf of the Institution, with responsibility for overseeing all
experimentation that involves the use of recombinant and synthetic nucleic acid
molecules.
Recombinant and synthetic nucleic acid molecule experiments have been grouped into
the following six categories by NIH. The first five (non-exempt) categories are subject to
IBC oversight.
1. Experiments that Require Institutional Biosafety Committee Approval, RAC
Review, and NIH Director Approval Before Initiation
o The deliberate transfer of a drug resistance trait to microorganisms that are not known to
acquire the trait naturally, if such acquisition could compromise the ability to control
disease agents in humans, veterinary medicine, or agriculture, will be reviewed by RAC.
2. Experiments that Require NIH/OBA and Institutional Biosafety Committee
Approval Before Initiation
o Experiments involving the deliberate formation of recombinant or synthetic nucleic acid
molecules containing genes for the biosynthesis of toxin molecules lethal for vertebrates
at an LD50 of less than 100 nanograms per kilogram body weight (e.g., microbial toxins
such as the botulinum toxins, tetanus toxin, diphtheriatoxin, and shigella dysenteriae
neurotoxin).
3. Experiments that Require Institutional Biosafety Committee Approval, and
Institutional Review Board Approvals and RAC Review before Research
Participant Enrollment
o Experiments involving the deliberate transfer of recombinant or synthetic nucleic acid
molecules, DNA or RNA Derived from Recombinant or synthetic nucleic acid molecules
into one or more human research participants. Note that RAC approval must be granted
before the IBC can approve any such protocol.
4. Experiments that Require Institutional Biosafety Committee Approval, Before
Initiation
o Experiments Using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as
Host-Vector Systems
o Experiments in Which DNA From Risk Group 2, Risk Group 3, Risk Group 4, or
Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic HostVector Systems
o
o
o
o
o
Experiments Involving the Use of Infectious DNA or RNA Viruses or Defective DNA or
RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems
Experiments Involving Whole Animals
Experiments Involving Whole Plants (involving use of pathogenic plant
microorganisms/insects, or recombinant plants with potentially hazardous properties)
Experiments Involving More than 10 Liters of Culture
Experiments Involving Influenza Viruses
5. Experiments that Require Institutional Biosafety Committee Notice Simultaneous
with Initiation
o Experiments not included in categories 1-4 or 6, are considered in category 5. All such
experiments may be conducted at BL1 containment. For example, experiments in which
all components derived from non-pathogenic prokaryotes and non-pathogenic lower
eukaryotes may be conducted at BL1 containment.
o Experiments Involving the Formation of Recombinant DNA Molecules Containing No
More than Two-Thirds of the Genome of any Eukaryotic Virus
o Experiments Involving Whole Plants (involving use of non-pathogenic plant
microorganisms, or recombinant plants with non-hazardous properties)
o Experiments Involving Transgenic Rodents - BSL1 ONLY (involving the generation of
rodents in which the animal's genome has been altered by the stable introduction of
recombinant or synthetic nucleic acid molecules or nucleic acids derived there from into
the germ-line).
6. Exempt Experiments
The following recombinant or synthetic nucleic acid molecules are exempt from the NIH
Guidelines and registration with the IBC is not required:
o
o
o
Those synthetic nucleic acids that: (1) can neither replicate nor generate nucleic acids that
can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that
do not contain an origin of replication or contain elements known to interact with either
DNA or RNA polymerase), and (2) are not designed to integrate into DNA, and (3) do
not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms
per kilogram body weight. If a synthetic nucleic acid is delibereately transferred into one
or more human research particpants and meets the criteria of Section III-C, it is not
exempt under this Section.
Those that are not in organisms, cells, or viruses and that have not been modified or
manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable
of penetrating cellular membranes.
Those that consist solely of the exact recombinant or synthetic nucleic acid sequence
from a single source that exists contemporaneously in nature.
o
o
o
o
o
o
Those that consist entirely of nucleic acids from a prokaryotic host, including its
indigenous plasmids or viruses when propagated only in that host (or a closely related
strain of the same species), or when transferred to another host by well-established
physiological means.
Those that consist entirely of nucleic acids from a eukaryotic host including its
chloroplasts, mitochonddria, or plasmids (but excluding viruses) when propagated only in
that host (or a closely related strain of the same species).
Those that consist entirely of DNA segments from different species that exchange DNA
by known physiological processes, though one or more of the segments may be a
synthetic equivalent. See Appendices A-1 through A-VI, Exemptions under Section III F6-Sublists of Natural Exchangers, for a list of natural exchangers that are exempt from
the NIH Guidelines.
Those genomic DNA molecules that have acquired a transposable element, provided the
transposable element does not contain any recombinant and/or synthetic DNA.
Those that do not present a significant risk to health or the environment as determined by
the NIH Director, with the advice of the RAC. See Appendix C, Exemptions under
Section III-F-8 for other classes of experiments which are exempt.
Additional information is available from NIH though their FAQ document for Exempt
Experiments.
Updated 10/29/13